EANS-News: Epigenomics AG / Epigenomics AG Announces Nine Months 2012 Financial Results

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quarterly report/molecular diagnostics

Berlin, Germany, and Seattle, WA, U.S.A. (euro adhoc) - Press release

Epigenomics AG Announces Nine Months 2012 Financial Results

Berlin, Germany, and Seattle, WA, U.S.A., November 7, 2012 -
Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American
cancer molecular diagnostics company, today announced its financial
results for the first nine months and third quarter ending September
30, 2012.

"During the third quarter of 2012, we made decisive steps forward
towards the completion of our ongoing head-to-head comparison study
between Epi proColon® and fecal immunochemical testing (FIT). The
results of this study should become available soon and thus allow us
to complete the Premarket Approval (PMA) application of our
blood-based colorectal cancer (CRC) screening test", said Dr. Thomas
Taapken, CEO/CFO of Epigenomics AG. "At this point, already ahead of
potential regulatory approval of our product, around 1,000 laboratory
developed Septin9 tests are being performed by our laboratory
partners every week in the United States. We expect these partners to
become future customers of Epi proColon®, once we potentially receive
regulatory approval for our test. At that time we also expect to be
able to expand the market significantly. Furthermore, we are making
all efforts necessary to create the awareness for the test and
generate the support in the medical and laboratory customer
communities in order to achieve the inclusion of the test in
screening guidelines and assure the availability of reimbursement by
insurance carriers."

9M/Q3 2012 Financial Results

* Revenue in Q3 2012 of EUR 272 thousand was slightly higher than the
comparable number for the previous year (Q3 2011: EUR 257 thousand)
due to an increase of R&D service fees which offsets a decrease in
licensing income. In the nine-month period, the decrease in revenue
compared to the same period in 2011 amounts to EUR 570 thousand and
is mainly attributable to a reduction in licensing income. * Like in
previous quarters of 2012 and in line with guidance, R&D costs
increased notably in Q3 2012 to EUR 2.3 million from EUR 1.1 million
in Q3 2011. This is mainly due to the ongoing FIT comparison study
and activities in connection with the FDA approval process. Moreover,
no capitalization of R&D expenses was recorded in 2012, compared to
EUR 0.8 million of capitalized development costs in Q3 2012. * SG&A
costs in Q3 2012 amounted to EUR 1.8 million. This significant
increase compared to EUR 1.4 million in Q3 2011 was mainly
attributable to the termination of the contract of Epigenomics'
former CEO Geert Walther Nygaard as of September 30, 2012. On a nine
month basis, SG&A costs were still slightly lower than in the
comparable period of 2011 (EUR 4.7 million vs. EUR 4.8 million). *
EBIT for Q3 2012 amounted to EUR -3.7 million - an improvement of
26.7% compared to Q3 2011 (EUR -5.0 million). EBIT for the first nine
months of 2012 was EUR 9.4 million (2011: EUR -10.7 million). * Net
loss for Q3 2012 amounted to EUR 3.7 million (Q3 2011: EUR 4.8
million) and for 9M 2012 to EUR 9.4 million (9M 2011: EUR 10.7
million). * Cash consumption in 9M 2012 was EUR 7.6 million (9M 2011:
EUR 8.8 million). * Liquidity at the end of the period amounted to
EUR 6.2 million (December 31, 2011: EUR 14.0 million).

Operational highlights

* FIT Comparison Study: The ongoing head-to-head comparison study
between Epi proColon® and FIT is on track since patient enrollment is
almost completed. Headline data from the study is expected to be
announced within weeks, allowing the company to complete the PMA
submission to the FDA before the end of the year. * Changes to the
Executive Management: On September 25, 2012, Epigenomics announced
the appointment of Dr. Thomas Taapken as sole member of the Executive
Board of the company, effective October 1, 2012. Geert Walther
Nygaard, previously CEO of Epigenomics, left the company, effective
September 30, 2012. * The responsibilities of Dr. Uwe Staub, former
Senior Vice President Research & Development, were expanded by
promoting him to Chief Operating Officer (COO) and granting him
"Prokura" (power of attorney). Among other duties, Dr. Staub is
responsible and oversees all activities in connection with the
development and the approval process for Epi proColon®.

Outlook

* Epigenomics actively continues to seek licensing and distribution
partners as well as key account customers for its products. Since
European marketing and sales efforts have been scaled down
significantly, an increase in product-derived revenues is not
expected prior to FDA approval of Epi proColon® (FDA decision on the
PMA application expected in the second half of 2013) and the ability
to sell Epi proColon® directly into the U.S. market. * The necessity
to invest into further clinical trials ahead of completion of the PMA
submission to the FDA, which arose earlier in 2012 as well as
additional one-time costs in connection with restructuring measures
will lead to higher full year costs in comparison to originally
announced plans for 2012. Nevertheless, operational costs are still
expected to be significantly below 2011 numbers. The company still
anticipates an improved EBIT and a narrowed net loss for 2012
compared to last year. * Going forward, Epigenomics strives to
significantly reduce the cash needs for 2013. Detailed financial
guidance for 2013 will be provided latest with the announcement of
full year 2012 results. * Epigenomics' current financial resources
are not sufficient to support the company's operations beyond the
first quarter of 2013 and will force management to secure additional
funds in the near future to remain operational in 2013 and beyond.
Since it is not anticipated that the company will be able to generate
sufficient cash flows from licensing income or from product sales in
the short term, Epigenomics is evaluating its options to raise
capital in the markets before the end of 2012 using all means it has
at its disposition, including issuance of shares and convertible
bonds.

Further Information

The full Nine Months Financial Report 2012 can be obtained from
Epigenomics' website at: http://www.epigenomics.com/en/news-investors
/investors/financial-reports.html

- Ends -

Contact Epigenomics AG

Antje Zeise
Manager IR | PR
Epigenomics AG
Tel +49 (0) 30 24345 368
ir@epigenomics.com
www.epigenomics.com

About Epigenomics Epigenomics (www.epigenomics.com) is a molecular
diagnostics company developing and commercializing a pipeline of
proprietary products for cancer. The Company's products enable
doctors to diagnose cancer earlier and more accurately, leading to
improved outcomes for patients. Epigenomics' lead product, Epi
proColon®, is a blood-based test for the early detection of
colorectal cancer, which is currently marketed in Europe and is in
development for the U.S.A. The Company's technology and products have
been validated through multiple partnerships with leading global
diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest
Diagnostics. Epigenomics is an international company with operations
in Europe and the U.S.A.

Epigenomics legal disclaimer This communication expressly or
implicitly contains certain forward-looking statements concerning
Epigenomics AG and its business. Such statements involve certain
known and unknown risks, uncertainties and other factors which could
cause the actual results, financial condition, performance or
achievements of Epigenomics AG to be materially different from any
future results, performance or achievements expressed or implied by
such forward-looking statements. Epigenomics AG is providing this
communication as of this date and does not undertake to update any
forward-looking statements contained herein as a result of new
information, future events or otherwise.

The information contained in this communication does not constitute
nor imply an offer to sell or transfer any product, and no product
based on this technology is currently available for sale by
Epigenomics in the United States or Canada. The analytical and
clinical performance characteristics of any Epigenomics product based
on this technology which may be sold at some future time in the U.S.
have not been established.

Further inquiry note:
Antje Zeise | CIRO
Manager IR/PR
Epigenomics AG
Tel: +49 30 24345 386

end of announcement euro adhoc
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company: Epigenomics AG
Kleine Präsidentenstraße 1
D-10178 Berlin
phone: +49 30 24345-0
FAX: +49 30 24345-555
mail: ir@epigenomics.com
WWW: http://www.epigenomics.com
sector: Biotechnology
ISIN: DE000A1K0516
indexes: Prime All Share, Technology All Share
stockmarkets: free trade: Berlin, München, Hamburg, Düsseldorf, Stuttgart,
regulated dealing/prime standard: Frankfurt
language: English